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An Immunonutritional Approach to the Prevention of Skin Cancer

NCT ID: NCT01032343

Last Updated: 2013-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-11-30

Brief Summary

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Skin cancer incidence continues to rise and ultraviolet radiation (UVR) in sunlight is the principal cause. Solar UVR can promote cancer development through its ability to suppress the immune system. The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids can protect human skin from UVR-induced immunosuppression.

Detailed Description

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Skin cancer is one of the most common human cancers with a rising incidence and considerable negative impact on human health. Exposure to ultraviolet radiation (UVR) in sunlight is the major aetiological factor in skin cancer initiation and progression. Human case-control studies have reported an inverse relationship between dietary fish or omega-3 polyunsaturated fatty acid (PUFA) intake and occurrence of non-melanoma skin cancer. Omega-3 PUFA have the potential to reduce the risk of photocarcinogenesis primarily by their ability to reduce production of prostaglandin E2 and consequently photoimmunosuppression. To date, no studies have assessed the impact of omega-3 PUFA on skin photoimmunosuppression in humans.

OBJECTIVE: To examine the potential of dietary omega-3 PUFA to protect against UVR-induced cutaneous immunosuppression in humans.

STUDY DESIGN: A double-blind randomised controlled nutritional study in 64 healthy human volunteers with nickel sensitivity. Volunteers will receive 3 months dietary supplementation with either omega-3 PUFA (n=32) or gelatine (n=32) both provided in identical gelatine capsules.

The aim is to quantify the influence of omega-3 PUFA on:

1. UVR-induced suppression of clinical contact hypersensitivity (CHS) responses
2. UVR-induced modulation of epidermal Langerhans cell trafficking
3. UVR-induced modulation of levels of immunoregulatory mediators

Conditions

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Skin Cancer

Keywords

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Immunosuppression Ultraviolet radiation Nickel Contact hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Omega-3 PUFA capsule

Group Type ACTIVE_COMPARATOR

Omega-3 PUFA

Intervention Type DIETARY_SUPPLEMENT

One capsule (4g omega-3 PUFA) daily for 3 months

Gelatine capsule

Group Type PLACEBO_COMPARATOR

Gelatine

Intervention Type DIETARY_SUPPLEMENT

One capsule daily for 3 months

Interventions

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Omega-3 PUFA

One capsule (4g omega-3 PUFA) daily for 3 months

Intervention Type DIETARY_SUPPLEMENT

Gelatine

One capsule daily for 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Pre-menopausal females
* Sun-reactive skin type I / II
* Reporting allergy to jewellery with nickel content

Exclusion Criteria

* History of atopy
* History of skin cancer
* History of a photosensitivity disorder
* Sunbathing (including sunbeds) in the last 3 months
* Pregnancy
* History of cardiac disease
* Taking photoactive medicine
* Not able to eat fish or gelatine
* Taking fish oil supplements prior to the study
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Lesley Rhodes

Professor of Experimental Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lesley E Rhodes, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Salford Royal NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Pilkington SM, Massey KA, Bennett SP, Al-Aasswad NM, Roshdy K, Gibbs NK, Friedmann PS, Nicolaou A, Rhodes LE. Randomized controlled trial of oral omega-3 PUFA in solar-simulated radiation-induced suppression of human cutaneous immune responses. Am J Clin Nutr. 2013 Mar;97(3):646-52. doi: 10.3945/ajcn.112.049494. Epub 2013 Jan 30.

Reference Type RESULT
PMID: 23364005 (View on PubMed)

Pilkington SM, Rhodes LE, Al-Aasswad NM, Massey KA, Nicolaou A. Impact of EPA ingestion on COX- and LOX-mediated eicosanoid synthesis in skin with and without a pro-inflammatory UVR challenge--report of a randomised controlled study in humans. Mol Nutr Food Res. 2014 Mar;58(3):580-90. doi: 10.1002/mnfr.201300405. Epub 2013 Dec 5.

Reference Type DERIVED
PMID: 24311515 (View on PubMed)

Related Links

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http://www.staffnet.manchester.ac.uk/volunteering/display/index.htm?id=149716

Study recruitment information

Other Identifiers

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UKCRN 6873

Identifier Type: REGISTRY

Identifier Source: secondary_id

AICR 08-0131

Identifier Type: -

Identifier Source: org_study_id